Oral human papillomavirus (HPV) and oral warts are common health concerns for HIV-infected people. This study will examine the frequency of oral HPV DNA shedding and oral warts in HIV-infected people who are enrolled in ACTG A5257 and who are beginning treatment with highly active antiretroviral therapy (HAART).

Quantitative changes in HPV DNA in oral specimens obtained from participants who have the same HPV subtypes at one of the two pre-HAART visits as well as at Week 16 or 24 [ Time Frame: Measured at Weeks 16 or 24 ] [ Designated as safety issue: No ]

Percentage and absolute number of CD4 cells that are interleukin (IL)-2+/interferon (IFN)+ or transforming growth factor (TGF)+ after HPV peptide stimulation measured from peripheral blood mononuclear cells (PBMCs) [ Time Frame: Measured during the A5272 study or obtained from stored specimens ] [ Designated as safety issue: No ]

Percentage and absolute number of CD8 cells that are IFN, tumor necrosis factor (TNF), TGF+, or CD107+ after HPV peptide stimulation measured from PBMCs [ Time Frame: Measured during the A5272 study or obtained from stored specimens ] [ Designated as safety issue: No ]

Percentage and absolute number of CD4 cells that are regulatory T cells (CD4+/CD25+/CD127low) measured from PBMCs [ Time Frame: Measured during the A5272 study or obtained from stored specimens ] [ Designated as safety issue: No ]

Percentage of CD4 cells and CD8 cells that express CD38 and HLA-DR [ Time Frame: Measured during the A5272 study or obtained from stored specimens ] [ Designated as safety issue: No ]

Persistence of HPV DNA of a specific type in throat wash specimens over the time course of the study [ Time Frame: Measured during the A5272 study or obtained from stored specimens ] [ Designated as safety issue: No ]

Salivary total lgA and anti-HPV lgA and S-lgA titers [ Time Frame: Measured during the A5272 study or obtained from stored specimens ] [ Designated as safety issue: No ]

Serum total anti-HPV lgG titers [ Time Frame: Measured during the A5272 study or obtained from stored specimens ] [ Designated as safety issue: No ]

Oral HPV infection occurs at a higher rate among HIV-infected people than among the general population. Recent research in the United States and Europe has also found that HIV-infected people have a higher risk of oral and oropharyngeal squamous cell cancer than HIV-uninfected people. In one study, it was found that HPV seropositivity was associated with an increased risk of squamous cell carcinoma of the oropharynx (SCCOP). In addition to SCCOP, another HPV-related health concern is oral warts, a condition for which there is no effective treatment. Even after beginning treatment with highly active antiretroviral therapy (HAART), active HPV replication in the mouth and oropharynx may persist in HIV-infected people, leading to an increased risk of SCCOP and oral warts. The purpose of this study is to evaluate the frequency of oral HPV DNA shedding and oral warts in HIV-infected people prior to HAART initiation and at regular time points after HAART initiation.

ACTG A5257 is a study that is comparing the effectiveness of three non-nucleoside reverse transcriptase inhibitor (NNRTI)-sparing HAART regimens in treatment-naïve participants. This study will enroll participants from the ACTG A5257 study. Participants will attend a baseline study visit at the same time as their ACTG A5257 baseline study visit. At baseline and at Week 4, 16, 24, and 48 study visits, participants will undergo an examination of their mouth, throat wash and saliva collection, and behavioral questionnaires. A blood collection will also occur at Week 24.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

Participants in this study will also be enrolled in ACTG A5257.

Criteria

Inclusion Criteria:

Meet inclusion criteria for and be enrolled in ACTG A5257

Ability and willingness of participant or legal guardian/representative to provide informed consent

Exclusion Criteria:

Co-enrollment in A5260s

Has begun receiving HAART as part of the A5257 study

Has ever received an HPV vaccine or plans to receive an HPV vaccine in the 6 months after study entry

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029249